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Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe Chronic Obstructive Pulmonary Disease (COPD)

This study is currently recruiting participants.
Verified January 2012 by Associazione Riabilitatori Insufficienza Respiratoria
Sponsor:
Information provided by (Responsible Party):
Marta Lazzeri, Associazione Riabilitatori Insufficienza Respiratoria
ClinicalTrials.gov Identifier:
NCT01198288
First received: September 7, 2010
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  Purpose

This study will investigate if adding a domiciliary respiratory physiotherapy treatment to standard care in patients with chronic obstructive pulmonary disease (COPD) can improve physical function (walking test) and quality of life.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Other: domiciliary rehabilitation
Other: Standard Care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial on the Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Associazione Riabilitatori Insufficienza Respiratoria:

Primary Outcome Measures:
  • meters as per walking test performance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Bode index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    This index is a combination of walking test result, Body Mass Index and respiratory measurement

  • dyspnea [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • relapses [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • services utilization [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )

  • meters as per walking test performance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Bode index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This index is a combination of walking test result, Body Mass Index and respiratory measurement

  • dyspnea [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • relapses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • services utilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )

  • meters as per walking test performance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Bode index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This index is a combination of walking test result, Body Mass Index and respiratory measurement

  • dyspnea [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • relapses [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • services utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )


Estimated Enrollment: 182
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Care

Drugs for COPD (as prescribed), oxygen therapy if needed*, check-up by the general practitioner and/or respirologist as usual.

Educational leaflet regarding optimization of oxygen therapy and drugs; Benefits of physical activity and proposal of a programme of exercise training; Energy conservation techniques; Nutritional counselling; Activity of daily Living (ADL) diary; Prevention and management of acute exacerbation

Monthly phone call with the aim of verifying:

  • the patients' clinical conditions;
  • the patient's adherence to the pharmacological treatments prescribed
  • the patient's compliance in filling out the clinical diary and the ADL diary
 Other: Standard Care
As describe in the standard care arm
Experimental: domiciliary rehabilitation

Same as the standard care group plus 10 (ten) home-based visits supervised by a specifically trained respiratory therapist (education+exercise training) Autonomous home-based programme: The patients will be given instructions and training in order to continue the exercise training programme on the days the respiratory therapist is not visiting them.

Counselling addressed at the outdoor activities.

 Other: domiciliary rehabilitation
a respiratory rehabilitation programme at the patient home

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe COPD (FEV1/FVC < 70% and FEV1 < 50% pred.) associated to hypoxaemic chronic respiratory insufficiency (PaO2 < 60mmHg) or
  • Very severe COPD (FEV1/FVC < 70% and FEV1 < 30% pred.)

With the following characteristics:

  • no signs of lung restriction (TLC≥80%)
  • clinically stable for at least the last four weeks
  • MRC ≥ 2
  • no participation to PR programmes in the last year

FEV1= Forced expiratory volume in the 1st second FVC= Forced vital capacity TLC= Total Lung Capacity PaO2= Partial pressure of arterial oxygen

Exclusion Criteria:

  • - Muscular-skeletal impairment that could limit the patient's participation to the exercise programme;
  • Cognitive impairment that could limit the patient's participation to the activities of education and exercise, as assessed by the Mini Mental State (MMS) test <26;
  • Malignancies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198288

Contacts
Contact: Marta Lazzeri presidenza@arirassociazione.org

Locations
Italy
Unità di pneunologia, Ospedale di Busto Arsizio Recruiting
Busto Arsizio, Varese, Italy
Sponsors and Collaborators
Associazione Riabilitatori Insufficienza Respiratoria
  More Information

No publications provided

Responsible Party: Marta Lazzeri, Dr, Associazione Riabilitatori Insufficienza Respiratoria
ClinicalTrials.gov Identifier: NCT01198288     History of Changes
Other Study ID Numbers: 01
Study First Received: September 7, 2010
Last Updated: January 30, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Associazione Riabilitatori Insufficienza Respiratoria:
COPD
Respiratory Physiotherapy

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 13, 2013